SHOPKO ALCOHOL FREE MULTI ACTION- cetylpyridinium chloride mouthwash

Shopko Alcohol Free Multi Action by

Drug Labeling and Warnings

Shopko Alcohol Free Multi Action by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis/Antiplaque

Uses

• helps reduce plaque that lead to:
• gingivitis
• bleeding gums

Warnings

Stop use and ask a dentist if

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swalowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
• Children 6 years to under 12 years of age: supervise use.
• Children under 6 years of age: do not use.

Other information

• this rinse is not intended to replace brushing or flossing.
• store at room temperature.

Inactive ingredients

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

Questions ro comments?

1-866-695-3030

Label Copy

INGREDIENTS AND APPEARANCE

SHOPKO ALCOHOL FREE MULTI ACTION 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-010-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/07/2018

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-010)